CEU Credits: 0.1
Course Code: ELM-263
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.1
Effective Date: 07/08/2024
Curriculum for this course
Three, Two, One…
Premanufacturing Steps
Regulations & GMP Guidelines
In-house vs CMOs
Quality Assurance
Batches
Batch Release Record Review: Who Does It?
Batch Release Record Review: What Gets Reviewed?
Drug Product Quality Testing
Aberrant Results
Testing Types
Other Investigations
Special Situations That May Impact Release
Releasing the Product
The Final Frontier
Test Your Knowledge!
v1.1 Minor update on 05/22/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.0 Course released on 09/16/2024